Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Device: Patient-controlled sedation; Device: Target-controlled infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01072435

2009-015564-34 (EudraCT Number)

a005c

Details and patient eligibility

About

Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).

Full description

80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective ERCP patients

Exclusion criteria

• allergy to propofol or opioid;
• inability to cooperate;
• ASA(American Society of Anaesthesiology)class greater than 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

patient-controlled sedation

Active Comparator group

Description:

PCS

Treatment:

Device: Patient-controlled sedation

target-controlled infusion

Active Comparator group

Description:

TCI

Treatment:

Device: Target-controlled infusion